| TAH Drug Code | IXOL |
|---|---|
| Indications | --Treatment of moderate to severe persistent asthma in adults and adolescents 12 years and older who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. |
| Dosing | Allergic asthma: The appropriate dose and frequency of Xolair is determined by baseline IgE (IU/ml), measured before the start of treatment, and body weight (kg). Prior to administration of the initial dose, patients should have their IgE level determined by any commercial serum total IgE assay for their dose assignment. Based on these measurements, 75 to 600 mg of Xolair in 1 to 4 injections may be needed for each administration. Chronic spontaneous urticaria(CSU): Usual dose: 150 or 300 mg every 4 weeks. Dosing for this indication is not dependent on serum IgE (free or total) level or body weight. |
| Hepatic Impairment | Dose adjustment not necessary |
| Renal Impairment | Dose adjustment not necessary |
| Contraindications | Hypersensitivity reaction to omalizumab or any component of the formulation |
| Adverse Effects | >10%: Central nervous system: Headache (6% to 12%) 1% to 10%: Cardiovascular: Peripheral edema (>2%) Central nervous system: Anxiety (>2%), migraine (>2%) Dermatologic: Alopecia (>2%) Gastrointestinal: Toothache (>2%) Genitourinary: Urinary tract infection (>2%) Infection: Fungal infection (>2%) Local: Injection site reaction (3%) Neuromuscular & skeletal: Arthralgia (3%), limb pain (>2%), musculoskeletal pain (>2%), myalgia (>2%) Respiratory: Nasopharyngitis (9%), sinusitis (5%), upper respiratory tract infection (3%), asthma (>2%), oropharyngeal pain (>2%), sinus headache (>2%), cough (2%), viral upper respiratory tract infection (<2%) Miscellaneous: Fever (>2%) All indications: <1% (Limited to important or life-threatening): Alopecia, anaphylaxis, antibody development, arthritis, chest tightness, Churg-Strauss syndrome, lymphadenopathy, malignant neoplasm, pulmonary hypertension, syncope, thrombocytopenia, transient ischemic attacks |
| Pregnancy | No (Limited) Human Data – Animal Data Suggest Low Risk |
| Lactation | No (Limited) Human Data - Potential Toxicity |
| More Info | UpToDate |